MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Swelling (2356)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported during a knee arthroscopy the procedure went very normal and the pump functioned properly without overpressure.The pump was at the same level as the operative site.All readings were normal and there was no excessive fluid noticed from the knee.However after the procedure and before closing it was noticed the patients calf was extremely swollen and very hard due to compartment syndrome.A fasciotomy was performed with a four to five inch incision which released the pressure and pure saline came out.This made an immediate relief to the calf area and it soon went back to the same size as the calf on the other leg.The doctor closed up the incision and is confident the problem is resolved.The doctor believes the patient had a tear in the knee capsule which lead to the fluid leaking down to the calf.Additional information obtained 05/21/2020: the procedure was on the patient's right leg.The pump used with the tubing was ar-6480, serial number (b)(4).Both the pump and tubing will be returned for evaluation.

Manufacturer Narrative

Complaint not confirmed.The returned ar-6480 was visually inspected and showing no scratches or damaged to the pump.Further review of the pump sub-assembly and components, showed no issues with the latch door or tubing connector.The returned ar-6480 dualwave arthroscopy fluid management system device was assembled with a new ar-6410 arthroscopy pump tubing were tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) hitting the pressure line connector before plugging into the pump.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10133011
• MDR Text Key: 194603859
• Report Number: 1220246-2020-01884
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Device Lot Number: 21811012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other